Engineering Lab Technician

Position Summary

The primary focus of this position is to assist R&D engineers in medical device process development and testing. This includes developing, optimizing, and validating processes for building medical devices; building units for engineering, pre-clinical, and clinical studies; marketing, and commercial sales. The role also involves setting up and operating manufacturing equipment.

Essential/Key Job Responsibilities

• Product Builds: Assist, coordinate, track, and build product parts or prototypes for engineering evaluation, validation, pre-clinical, and clinical studies, marketing, and commercial sales. Set up and operate manufacturing equipment.
• Process Development: Assist in new process development for new or existing medical devices and processes, supporting tooling and equipment development. Assist in conceptual input to the design of fixtures, tooling, and equipment, and assist with the recommendation, specification, and procurement of capital equipment.
• Documentation: Assist, prepare, develop, and implement documentation including work instructions, standard operating procedures, technical reports, change requests, and formal test protocols and reports that comply with GMP and Quality requirements.
• Test Method Development: Review test methods during test method development and assist with test method validations.
• Testing: Perform tests by following instructions from development engineers; collect data and record test results; analyze test data, organize, and present when necessary in a reportable format. Assist in the execution of test protocols and procedures. Set up test equipment for testing according to protocols.
• Training: Provide process/test method training to manufacturing and QA personnel.
• Equipment: Perform and document equipment preventative maintenance and repairs on manufacturing equipment and systems per schedule. Ensure equipment operates properly. Obtain quotes for testing and calibration.
• Materials/Inventory: Generate purchase orders, coordinate orders and deliveries with vendors, R&D stock checking, shipping materials, receiving materials, preparing commercial invoices, and liaise with internal Customs specialists.
• Mentoring/coaching: Peer-peer coaching other technicians on R&D-based tasks and responsibilities.
• Other Responsibilities: Support Manufacturing, Quality, Regulatory, and R&D to ensure compliance with all internal and external guidelines.

Required Qualifications

• Proficiency in computer skills (MS Windows, MS Outlook, Word, Excel, and PowerPoint) and ability to enter data in Microsoft Project and / or Minitab for data analysis.
• Ability to analyze and evaluate data and recommend actions; has practical knowledge of root cause and statistical methods and analysis.
• Ability to work and manage priorities with little supervision.
• Strong written and verbal communications skills; able to convey project status and escalate issues efficiently and clearly.

Preferred Qualifications

• Experience working in a laboratory or a controlled environment (cleanroom) with knowledge of GMP and GLP.
• Experience with building or testing components and products.
• Ability to operate lab equipment with practical and technical knowledge of common lab instrumentation and equipment.
• Familiarity with process validation (IQ, OQ, and PQ); ability to assist in executing validation.
• Experience in medical device or other regulated FDA/QSR and ISO environment.
• Ability to design (fixtures, equipment, and testing).
• General technical awareness of rapid prototyping techniques and an ability to read and understand CAD drawings (e.g., Solidworks).

Education and/or Experience

• Education: High diploma required; Associates degree or higher in science, math, or engineering preferred.
• Experience: 2 years of relevant work experience such as experience as a laboratory technician or manufacturing operator, or Associates degree in science, math, or engineering with 1 year relevant work experience.